NCT07088159Available不适用
Intermediate-size Patient Population Expanded Access Protocol for Tazbentetol in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)
Spinogenix27 个研究点 分布在 1 个国家开始时间: 2025年7月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 发起方
- 试验地点
- 27
研究概览
简要总结
The purpose of this Expanded Access Program is to provide tazbentetol to ALS patients who are not eligible to enroll in an ALS clinical trial. This Expanded Access Program will assess safety and tolerability, and clinical efficacy of tazbentelol.
详细描述
This is a multi-site, intermediate-size patient population expanded access protocol developed to provide compassionate use access to tazbentetol to adult patients with ALS who have progressed following available standard of care.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALS diagnosis
- •Age 18 -85 years at time of signing informed consent form
- •Ineligible for other interventional ALS clinical research participation
- •Vital Capacity greater than 35% of predicted capacity for age, height, and sex
- •If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking tazbentetol.
- •Life expectancy of at least 6 months, according to Investigator's judgement
排除标准
- •Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient
- •Known ongoing or clinically uncontrolled cardiac disease
- •Clinically significant liver disease
- •Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement
- •Concomitant use of another investigational medical product for treatment of ALS
- •Unable to reliably and regularly swallow whole oral medications on a daily basis
研究者
研究点 (27)
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